How much products liability insurance does a medical device manufacturer need?

The right products liability limit for a medical device manufacturer is driven by the severity of the device and by the contracts the company signs, not by revenue alone. A lower-risk Class I or II accessory maker often starts with a $1M/$2M primary products and completed operations limit plus a $5M umbrella, while implantable, life-sustaining, or Class III devices, and companies selling into hospital systems, commonly carry $10M or more.

The most common forcing function is the contract. Hospital purchase agreements and group purchasing organization (GPO) contracts frequently specify a required combined limit and additional-insured status for products and completed operations, and that requirement often sets the number the manufacturer must carry. Distribution scale and geography matter too, since broader distribution raises the aggregate exposure.

The practical step is to size the primary products limit to satisfy the base contract requirement, add an umbrella to reach the combined limit hospitals and GPOs demand, and review each major purchase agreement before signing so the manufacturer is not found short at contract time.